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1. WO1997016119 - SYSTEME D'OBTURATION SEPTALE DE TYPE PARAPLUIE A CENTRAGE AUTOMATIQUE

Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

[ EN ]

Self-Centering Umbrella-Type Septal Closure Device

Field ofthe Invention
The invention relates to a self-centering umbrella-type septal closure device which is provided with a support structure having a plurality of arms to support each ofthe proximal and distal occlusion shells. Each ofthe proximal and distal support arms has at least three coils any one or more of which is secured by a centering means so as to control the positioning ofthe closure device within and over a defect and permit the use of a smaller size device for a given defect.

Background ofthe Invention

The human heart is divided into four compartments or chambers. The left and right atria are located in the upper portion ofthe heart and the left and right ventricles are located in the lower portion ofthe heart. The left and right atria are separated from each other by a muscular wall, the intraatrial septum, while the ventricles are separated by the intraventricular septum.

Either congenitally or by acquisition, abnormal openings, holes or shunts can occur between the chambers ofthe heart or the great vessels, causing shunting of blood through the opening. Such deformities are usually congenital and result from the incomplete formation ofthe septum, or wall, between chambers during fetal life when the heart forms from a folded tube into a four chambered, two unit system. These deformities can cause significant problems.
Ultimately, the ill effects of these defects cause added strain on the heart which may result in heart failure if the defects are not corrected.

Steps have been taken to correct such defects. Prior to recent developments relating to the occlusion of septal defects, extensive surgery was required. The first transcatheter occlusion of patent ductus arteriosus was performed by Posner (in Germany) by transarterially utilizing an Ivalon foam plug. Since that time, this method has been used primarily by German and Japanese investigators in adult and older children. However, this procedure requires a large femoral artery for entry and is known to have significant arterial complications. Consequently, various attempts have been made to close intraatrial defects without surgery.

Prior to the present invention, several defect closure devices have been proposed for closing off intracardiac shunts as an alternative to surgical closure. For example, in U.S. Patent No. 3,874,388, King et al. disclose an umbrella-like closure device to cover both sides of a shunt defect. Specifically, the device comprises a pair of opposed umbrella-like elements that can be snap-locked together in face-to-face relationship to occlude a defect. Each ofthe umbrella-like elements includes supporting struts attached to a central hub in a manner permitting the struts to pivot from a position substantially parallel to the central axis ofthe umbrella-like elements to a position substantially perpendicular to the central axis. Material such as polyester, PTFE, nylon, silastic, pericardium or silk is mounted on the struts and acts to occlude the septal defect once the device has been opened and positioned. Barbs are located on the tips ofthe struts to engage the septal wall around the defect and maintain the position ofthe device relative to the defect.

U.S. Patent No. 4,007,743 to Blake describes another umbrella-like shunt closure device. The Blake '743 patent discloses a device having a series of foldable sections positioned between each ofthe umbrella arms. The sections automatically open the arms once the device is pushed out and is free ofthe catheter. Like the King device, Blake requires that the umbrella-like closure elements be snap-locked to each other in vivo.

U.S. Patent No. 4,917,089 to Sideris relates to a device and process for the occlusion of intracardiac defects. Two independent components are connected across the defect by a button-type closure. The closure apparatus comprises an occluder positioned on the distal side ofthe defect and an occluder-holder positioned on the proximal side ofthe defect.

All of these designs are difficult to position and deploy. This is especially a problem with a device having barbs. With such a device, an initial misplacement can result in potentially disastrous consequences because such a device can not generally be repositioned.

Early clamshell occlusion devices were typically much larger than the defect. Such a configuration was utilized to ensure that the defect was covered and to compensate for slippage between the occlusion members at the location ofthe defect.

Larger occlusion devices, however, may not fit within the heart chamber without interfering with other anatomical parts, particularly valves. Additionally, larger devices are subjected to higher stress levels within the atrial chamber, resulting in a greater potential for fractures ofthe occlusion device due to fatigue loading. Such occurs because larger devices are forced further from the septal wall due to the curvature ofthe walls o the atrial chamber

In view ofthe limitations ofthe prior art structures discussed above, a smaller, improved occlusion device is needed. The present invention provides such a device.

Summary ofthe Invention

It is therefore an object ofthe present invention to provide an umbrella-type septal closure device which can self-center within and over a defect.

Another object ofthe present invention is to provide an umbrella-type septal closure device that is less than twice the size ofthe defect to be closed.

It is also an object ofthe present invention to provide an umbrella-type septal closure device which can be effectively used when it is about 1.2 to about 1.8 times the size ofthe defect to be closed.

A further object ofthe present invention is to provide an umbrella-type septal closure device that will remain centered within a defect after the device has been introduced and minimize misalignment ofthe occluders relative to the defect.

These and other objects are achieved by the present invention which provides an umbrella-type septal closure device which can self-center within a defect. The device includes a proximal occluder having a plurality of arms supporting an occlusion shell, a distal occluder having a plurality of arms supporting an occlusion shell, and a centering mechanism secured to at least one ofthe proximal occluder support arms and to at least one ofthe distal occluder support arms to center the proximal and distal occluders about a defect.

Other objects, advantages, and salient features ofthe invention will become apparent from the following detailed description, which taken in conjunction with the annexed drawings, discloses the preferred embodiments ofthe present invention.

Brief Description ofthe Drawings

This invention is pointed out with particularity in the appended claims. The above and further advantages of this invention may be better understood by referring to the following description taken in conjunction with the accompanying drawings, in which:

Figure 1 is a top plan view of a first embodiment.

Figure 2 is a top plan view of an alternate version ofthe first embodiment.

Figure 3 is a top plan view of a further version ofthe first embodiment.

Figures 4 and 5 are top plan views of a second embodiment.

Figure 6 is a top plan view of a third embodiment.

Figure 7 is a cross-sectional view ofthe third embodiment.

Figure 8 is a top plan view of an alternate version ofthe third embodiment.

Figure 9 is a cross-sectional view ofthe alternate version ofthe third embodiment.

Figure 10 is a cross-sectional view of a fourth embodiment.

Figure 1 1 is a top schematic view of a septal closure device without the centering device ofthe present invention in a defect.

Figure 12 is a top schematic view ofthe septal closure device ofthe present invention centered about a defect.

Detailed Description ofthe Invention

The invention is directed to a self-centering umbrella-type septal closure device. The self-centering mechanism employed in the present invention controls the positioning ofthe septal closure device so that the device will be centered about a defect and thereby prevent the occluder members ofthe closure device from being misaligned across the defect. The centering mechanism ofthe present invention also allows for the use of umbrella-type septal closure devices that are as small as about 1.2 to about 1.8 times the size ofthe defect, thus reducing the mechanical stress levels after deployment in the atrial chambers, the risk of fracturing the support arms ofthe occluder device due to fatigue loading, and the chances for interference with other cardiac structures.

Generally, the umbrella-type self-centering septal closure device comprises a proximal occluder, a distal occluder and a centering structure secured to both the proximal occluder and the distal occluder to control the positioning ofthe proximal and distal occluders so that they are centered about a defect. The centering structure includes at least one centering member secured to the proximal and distal occluders.

Several embodiments ofthe present invention are discussed below. Each embodiment is discussed in conjunction with the same type of septal closure device, namely the umbrella-type occluder which is disclosed in U.S. Patent No. 5,425,744 owned by the assignee ofthe present invention, said patent being incorporated herein by reference. The umbrella-type occluder includes two umbrella-like occlusion members attached at a center point. Each umbrella is supported by at least three outwardly extending arms preferably having three or more resilient coils radially spaced from the center point Resilient coils are preferred because they are less likely to fracture due to fatigue loading; and they allow the occluder to be temporarily deformed in order to fit into a deployment mechanism.

When the umbrella-type occluder is used without the centering device ofthe present invention, the occluders must be accurately sized to approximately twice the diameter ofthe defect (approximately 1.8-2.8 for atrial septal defects) as measured angiographically with a sizing balloon. As shown in Fig. 11, the primary reason for sizing the occluders to about twice the size ofthe defect, is the inability ofthe occluders to center within the defect. While the umbrella-type occluder may be useful for small defects, larger defects (>20 mm.) must be closed surgically due to limitations associated with existing device sizes.

It should be noted that while the centering device ofthe present invention is discussed in conjunction with a particular umbrella-type occluder device such discussion is for illustration only and does not limit the scope ofthe invention which may be used with other umbrella-type occluders.

As shown in Figs. 1-10, septal occluder 10 comprises a proximal occluder 12 and a distal occluder 14, and includes an overall support structure 16 for supporting a generally square proximal occlusion shell 18 and a square distal occlusion shell 20. The support structure is preferably manufactured from MP35N® alloy sold by the Carpenter Steel Division of Carpenter Technology, located in Reading, Pennsylvania, or Maryland Specialty Wire, Inc., located in Cockeysville, Maryland. The MP35N® alloy is a non-magnetic, nickel-cobalt-chromium-molybdenum alloy having high tensil strength, good ductility and corrosion resistance. The alloy which conforms to the American Society for Testing and Materials' F562 standard, has the elemental composition as shown in Table 1. The shells may be preferably constructed from a knitted polyester fabric. The shells are each sewn as at 22, with a polyester suture, to the facing sides of proximal support structure 24 and distal support structure 34.

Each ofthe proximal and distal support structures includes at least three outwardly extending arms. Fig. 1 shows the proximal support structure 24 having four outwardly extending arms 26, 28, 30, and 32 and the distal support structure 34 similarly having four outwardly extending arms 36, 38, 40, and 42. Each outwardly extending arm is resiliently biased and preferably includes, in one embodiment, a shoulder coil 26a, an elbow coil 26b, a wrist coil 26c, and a suture coil 26d.

The overall support structure 16 is constructed from four spring arm subassemblies 44, 46, 48, and 50. As a result, two arms are formed from a single piece of metal. Specifically, first proximal arm 26 and first distal arm 36, second proximal arm 28 and second distal arm 38, third proximal arm 30 and third distal arm 40, and fourth proximal arm 32 and fourth distal arm 42 are respectively subassemblies 44, 46, 48, and 50. In one embodiment, the four subassemblies can be mechanically secured together by wire 52 with adjacent subassemblies offset by 90°. Other means such as laser welding can be used to secure the four subassemblies together.

While the preferred embodiment discloses an occlusion device that is square, other shapes may be utilized without departing from the spirit ofthe present invention. Additionally, while each arm ofthe occluder is resiliently biased as a result ofthe shoulder, elbow, and wrist coils, other resilient structures could be utilized in constructing the framework for the occlusion shells.

With reference to Figs. 1 through 3 the first embodiment ofthe present invention is disclosed. As stated previously, septal occluder 10 includes proximal occluder 12 with four arms that are opened on one side of a defect and distal occluder 14 with four arms that are opened on the other side ofthe defect. The first embodiment provides four centering members 54, 56, 58, and 60 secured between the arms ofthe proximal and distal occluders. The centering members 54, 56, 58, and 60 may be made of elastomeric, biocompatible polymeric materials. The centering members preferably have the properties of long term biocompatability, toughness, resiliency, high elongation and ease of processing into a monofilament. Potential materials for the centering members include natural rubber (latex) or various thermoplastic elastomers such as Hytrel (PBT PEO block copolymers), PEBA (polyether amide block copolymers), or SBS (styrene butadiene styrene)/SEBS (styrene ethylene butadiene styrene) block copolymers.

Three connection patterns for the centering members are shown in Figures 1-3, although other connection patterns are possible without departing from the spirit and scope ofthe present invention. With reference to Fig. 1, centering members 54, 56, 58, and 60 are secured to elbow coils of adjacent distal arms and proximal arms. Specifically, a first centering member 54 is connected between the elbow coil 26b ofthe first proximal arm 26 and the elbow coil 36b ofthe first distal arm 36, a second centering member 56 is connected between the elbow coil 28b ofthe second proximal arm 28 and the elbow coil 38b ofthe second distal arm 38, a third centering member 58 is connected between the elbow coil 30b ofthe third proximal arm 30 and the elbow coil 40b ofthe third distal arm 40, and a fourth centering member 60 is connected between the elbow coil 32b ofthe fourth proximal arm 32 and the elbow coil 42b ofthe fourth distal arm 42.

Another connection pattern is shown in Fig. 2, where the centering members 54', 56', 58', and 60' are secured between the wrist coils of adjacent proximal and distal arms. Specifically, a first centering member 54' is connected between the w ist coil 26c ofthe first proximal arm 26 and the wrist coil 36c ofthe first distal arm 36, a second centering member 56' is connected between the wrist coil 28c ofthe second proximal arm 28 and the wrist coil 38c ofthe second distal arm 38, a third centering member 58' is connected between the wrist coil 30c ofthe third proximal arm 30 and the wrist coil 40c ofthe third distal arm 40, and a fourth centering member 60' is connected between the wrist coil 32c ofthe fourth proximal arm 32 and the wrist coil 42c of the fourth distal arm 42.

Figure 3 illustrates a third connection pattern, with the centering members 54", 56", 58", and 60" being connected between wrist coils of diametrically opposed proximal arms and distal arms. Specifically, a first centering member 54" is connected between the wrist coil 26c ofthe first proximal arm 26 and the wrist coil 40c ofthe third distal arm 40, a second centering member 56" is connected between the wrist coil 28c ofthe second proximal arm 28 and the wrist coil 42c ofthe fourth distal arm 42, a third centering member 58" is connected between the wrist coil 30c ofthe third proximal arm 30 and the wrist coil 36c ofthe first distal arm 36, and a fourth centering member 60" is connected between the wrist coil 32c ofthe fourth proximal arm 32 and the wrist coil 38c ofthe second distal arm 38. Attachment between wrist coils of diametrically opposed proximal and distal arms minimizes the stretching ofthe centering members during loading ofthe occluder into the delivery system, although the degree of centering may be somewhat decreased.

With reference to Figs. 4 and 5, a second embodiment ofthe present invention is shown.

Briefly, the second embodiment utilizes a centering suture 62 threaded through the coils ofthe proximal and distal arms ofthe septal occluder 10. In accordance with the second embodiment, a self-centering septal closure device is produced by threading the centering suture 62 through shoulder coil 26a ofthe first proximal arm 26 and subsequently threading the centering suture 62 through the elbow coil 26b ofthe first proximal arm 26. The suture 62 is then threaded through the elbow coil 36b ofthe first distal arm 36. The procedure is continued, alternately threading the suture 62 through the elbow coils ofthe proximal and distal arms until the suture 62 is looped through the elbow coil 26b ofthe first proximal arm 26 for a second time. At this point, the suture 62 is threaded through the shoulder coil 26a ofthe first proximal arm 26 for a second time, and both ends ofthe suture are accessible from the proximal side. Figure 4 shows the device with the centering suture fully relaxed, while Fig. 5 shows the suture in a tensioned state.

Another threading pattern that can be used to produce a self-centering septal closure device involves threading the centering suture 62 through shoulder coil 26a ofthe first proximal arm 26 and subsequently threading the centering suture 62 through the wrist coil 26c ofthe first proximal arm 26. The suture 62 is then threaded through the wrist coil 36c ofthe first distal arm 36. The procedure is continued, alternately threading the suture 62 through the wrist coils ofthe proximal and distal arms until the suture 62 is looped through the wrist coil 26c ofthe first proximal arm 26 for a second time. At this point, the suture 62 is threaded through the shoulder coil 26a ofthe first proximal arm 26 for a second time, and both ends ofthe suture are accessible from the proximal side.

Referring again to the first threading pattern ofthe second embodiment discussed above, once the occluders are placed across the defect, the suture can be pulled to eliminate the slack between the elbow coils. This creates a larger centered diameter. As a result, the likelihood of the device moving off center is minimized. The centering suture can be adjusted to accommodate odd shaped defects. This can be accomplished with the use of a slip knot or one-way knot. Once the suture is pulled to eliminate the slack, the centering suture can be trimmed off by mechanical means. It should be noted that while two threading patterns have been disclosed, it may be possible to utilize other threading patterns without departing from the spirit and scope ofthe present invention.

A third embodiment ofthe present invention is shown in Figs. 6, 7, 8 and 9. According to the third embodiment, four centering members made of either a polymer or metal shape memory material are connected between the proximal arms 26, 28, 30, and 32 and distal arms 36, 38, 40, and 42. Figures 6 through 9 show the centering members connected between wrist coils of adjacent proximal arms and distal arms in the same pattern as shown with regard to the second connection pattern ofthe first embodiment (see Fig. 2), although other connection patterns such as those shown in Figures 1 and 3 could be used without departing from the spirit ofthe present invention.

The centering members 64, 66, 68, and 70 shown in Figs. 6 and 7 are made of polymer shape memory materials. Polymer shape memory materials deform because of stretching during loading ofthe device and then return to their prior shape after exposure to body temperature. Alternatively, the centering members can be polymer shape memory materials which are initially long enough for loading into a delivery system (with no force required to stretch) and which shrink after exposure to body temperature inside the patient.

Another variation on the use of shape memory materials is shown in Figs. 8 and 9, where the centering members 64', 66', 68', and 70' are pieces of small diameter wire made from a shape memory metal, such as Ni-Ti (nitinol). The connecting members may be secured between the wrist coils of adjacent proximal arms and distal arms in the same pattern as shown with respect to the second connection pattem ofthe first embodiment (See Fig. 2) although other connection patterns could be used. The centering members 64', 66', 68', and 70' are set to re-form into a shorter wire upon exposure to body temperature within the patient. This version is advantageous in that it requires no force to deform during loading, has a low profile and good frictional properties, and is less prone to damage during loading.

A fourth embodiment is shown in Fig. 10. As with the first embodiment, the fourth embodiment uses four resilient centering members 72, 74 (two are not shown) secured between the proximal arms 26, 28, 30, and 32 and the distal arms 36, 38, 40, and 42. In contrast to the first embodiment, the centering members ofthe fourth embodiment are metal (or plastic) springs secured between the wrist coils of adjacent proximal arms and distal arms. Specifically, the centering members are secured between wrist coils of adjacent proximal arms and distal arms in the same pattern as shown with regard to the second connection pattern ofthe first embodiment (see Fig. 2), although other connection patterns could be used without departing from the spirit of the present invention.

Use of a plastic or metal spring still requires the application of force to stretch the spring during loading, but there is the advantage of having the flexibility to use various materials for the spring including MP35N® from which the occluder framework is fabricated.

Metallic embodiments three and four simplify finding materials with physical properties and biocompatability for long term implantation. Additionally, since the materials used in embodiments three and four are likely to be closer in stiffness to the arms ofthe occluder, it is unlikely that the force required to stretch the filaments could damage the occluder arms. Finally, embodiments three and four may be helpful in limiting the overall profile ofthe device when it is loaded into the delivery system. This would result in lowering the loading friction ofthe device.

Each ofthe preferred embodiments are self-centering umbrella-type septal closure devices, which greatly reduce the size ofthe occluders necessary to properly close a defect. This is accomplished by the centering members which form an outer boundary preventing the septal closure device from moving substantially off-center within a defect.

With reference to Figs. 1 1 and 12, a septal closure device 10 without the centering members and one ofthe present septal closure devices 1 is shown, respectively. With reference to Fig. 11, the septal closure device 10 has a wide range of movement about the defect 80, and can easily move off-center. In contrast, the centering member(s) ofthe present septal closure device 1 (Fig. 12) create a boundary 82 which retains the septal closure device 1 about the center ofthe defect 80.

The centering septal occluder 10 is deployed in the same manner as other occluders. A sheath is first inserted into the defect as performed by one skilled in the art. The occluder 10 is then loaded into a catheter, which is inserted through the sheath. The distal occluder 14 of the occluder 10 is released into the distal heart chamber through the sheath. The sheath and catheter are then pulled back into the proximal heart chamber, where the proximal occluder 12 ofthe device 10 is deployed. Once deployed, centering members, generally, 54, 56, 58, and 60 contact the edges ofthe defect, centering the device 10 in the defect. Once correct position is confirmed, the device 10 is released from the catheter and the catheter is withdrawn.

While the preferred embodiments ofthe present invention have been shown and described, it should be understood that it is intended to cover all modifications and alternate methods falling within the spirit and scope ofthe invention as defined in the appended claims or their equivalents.

Having described preferred embodiments ofthe invention, it will now become apparent to one of skill in the art that other embodiments incorporating the concepts may be used. It is felt, therefore, that these embodiments should not be limited to disclosed embodiments but rather should be limited only by the spirit and scope ofthe following claims.

Table 1
Carbon 0.025% max Nickel 33.00/37.00%

Manganese 0.15% max Molybdenum 9.00/10.50%

Silicon 0.15% max Cobalt Balance

Phosphorus 0.015% max Titanium 1.00% max

Sulfur 0.010% max Boron 0.010%

Chromium 19.00/21.00% Iron 1.00% max